The Coalition for Health AI is pushing back after senior White House and HHS officials accused the organization of overstepping its role in healthcare AI policy, describing it as a potential “regulatory cartel.”
In an Oct. 8 post on X, HHS Secretary Robert F. Kennedy Jr. praised an op-ed by Deputy HHS Secretary Jim O’Neill and FDA Commissioner Marty Makary calling for reduced federal barriers to AI innovation.
“We must not let the Coalition for Health AI (CHAI) build a regulatory cartel,” Mr. Kennedy wrote.
The comments follow an earlier Politico report indicating that HHS has broken from the previous administration’s stance on AI oversight, rejecting a private-sector vetting initiative led by CHAI. Mr. O’Neill told Politico that HHS does not support the coalition and emphasized that the group holds no regulatory authority.
“They don’t speak for us,” Mr. O’Neill told the news outlet, describing CHAI as a potential “cartel” that could pressure startups to join in order to compete. In a follow-up interview, he said his intent was to correct “the perception that this organization is a regulator or a super pseudo regulator.”
CHAI, founded in 2022 and led by CEO Brian Anderson, MD, counts more than 3,000 members including technology firms such as Microsoft and health systems including Mayo Clinic (Rochester, Minn.) and Duke Health (Durham, N.C.). The group has established two assurance labs and partnered with The Joint Commission to issue AI guidance.
In a letter to members this week, Dr. Anderson acknowledged “recent public attention on CHAI’s role and engagement with federal partners” and sought to clarify its purpose.
“We develop frameworks and best practices that reflect the consensus of that work in order to scale meaningful AI adoption and ensure better outcomes. This collective knowledge helps inform those who are responsible for ensuring AI’s effectiveness, safety and impact,” Dr. Anderson wrote in the letter shared with Becker’s. “CHAI has no regulatory mission or role.”
Dr. Anderson said he plans to engage directly with Mr. O’Neill’s office “to better understand any concerns” and to explore collaboration on shared goals “to accelerate the rapid innovation and development of health AI.”
The organization has maintained that its work is voluntary and designed to inform — not replace — federal rulemaking. Dr. Anderson said CHAI’s strategy aligns with the administration’s AI Action Plan, the Executive Order on Removing Barriers to American Leadership in AI and the intent of Sen. Ted Cruz’s SANDBOX Act, which seeks to ease restrictions on AI testing and deployment.
Mr. Makary has also voiced caution about CHAI’s influence. The agency, which regulates certain AI-enabled medical devices, recently issued a request for information to gather feedback on how AI performance should be evaluated.
